MAUDE Adverse Event Report: PRODUCTOS MEDLINE MEDLINE; LUMBAR PUNCTURE TRAY 22GX3.5

Catalog Number	DYNJTS4306
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Lumbar drain was being removed in standard procedure with the patient in lateral decubitus position.Lumbar drain did not have any resistance but at the end snapped and broke off tip within the soft tissue of the patient's body.No pain by the patient.
Additional Manufacturer Narrative
According to the customer, when removing a lumbar drain on (b)(6) 2026 from the patient's back, the "tip" broke and was left inside the patient's back.The customer reported that there was no injury as a result of the reported incident, "imaging", and the tip was left inside the patient.The customer reported that they were prescribed "an oral medication and cream to apply to the area".The customer did not report any serious injury, medical intervention, or follow-up care related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: LUMBAR PUNCTURE TRAY 22GX3.5
• Manufacturer (Section D): PRODUCTOS MEDLINE; blvd world trade center no 106; parque industrial oradel; nuevo laredo tamaulipas, 88285 ; MX 88285
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24501583
• Report Number: 3004122598-2026-00001
• Device Sequence Number: 9960751
• Product Code: OJH
• UDI-Device Identifier: 10889942602261
• UDI-Public: 10889942602261
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJTS4306
• Device Lot Number: 25HBW277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic